Catalog Number

29144

Brand Name

Nobel Biocare®

Version/Model Number

29144

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2020

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NDP

Product Code Name

Accessories, implant, dental, endosseous

Public Device Record Key

cf0a2200-bf11-47f3-abfc-3aea3de9f22a

Public Version Date

April 26, 2021

Public Version Number

2

DI Record Publish Date

June 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-